Mining and Analysis of Adverse Event Signals of Isotretinoin Based on the Real-World Data of FAERS Database

The study analyzed 46,526 adverse event reports related to isotretinoin from the FAERS database, identifying 445 significant adverse events, including 38 previously unlabeled ones such as Dandy-Walker syndrome, childhood depression, and suicidal ideation. Gastrointestinal disorders were the most frequently reported. The findings highlight the need for updated drug labels and enhanced safety measures, particularly concerning teratogenicity and psychiatric risks. The study emphasizes the importance of ongoing pharmacovigilance to refine isotretinoin's safety profile and guide clinical decision-making, while acknowledging limitations like underreporting and lack of causality confirmation in the FAERS database.